Samip Vasaiwala

Testosterone Supplementation in Heart Failure: A Meta-Analysis

Background— Low testosterone is an independent predictor of reduced exercise capacity and poor clinical outcomes in patients with heart failure (HF). We sought to determine whether testosterone therapy improves exercise capacity in patients with stable chronic HF. Methods and Results— We searched Medline, Embase, Web of Science, and Cochrane Central Register of Controlled Trials (1980–2010). Eligible studies included randomized controlled trials (RCTs) reporting the effects of testosterone on exercise capacity in patients with HF. Reviewers determined the methodological quality of studies and collected descriptive, quality, and outcome data. Four trials (n=198; men, 84%; mean age, 67 years) were identified that reported the 6-minute walk test (2 RCTs), incremental shuttle walk test (2 RCTs), or peak oxygen consumption (2 RCTs) to assess exercise capacity after up to 52 weeks of treatment. Testosterone therapy was associated with a significant improvement in exercise capacity compared with placebo. The mean increase in the 6-minute walk test, incremental shuttle walk test, and peak oxygen consumption between the testosterone and placebo groups was 54.0 m (95% CI, 43.0–65.0 m), 46.7 m (95% CI, 12.6–80.9 m), and 2.70 mL/kg per min (95% CI, 2.68–2.72 mL/kg per min), respectively. Testosterone therapy was associated with a significant increase in exercise capacity as measured by units of pooled SDs (net effect, 0.52 SD; 95% CI, 0.10–0.94 SD). No significant adverse cardiovascular events were noted. Conclusions— Given the unmet clinical needs, testosterone appears to be a promising therapy to improve functional capacity in patients with HF. Adequately powered RCTs are required to assess the benefits of testosterone in this high-risk population with regard to quality of life, clinical events, and safety.

Handcarried Ultrasound Measurement of the Inferior Vena Cava for Assessment of Intravascular Volume Status in the Outpatient Hemodialysis Clinic

Accurate intravascular volume assessment is critical in the treatment of patients who receive chronic hemodialysis (HD) therapy. Clinically assessed dry weight is a poor surrogate of intravascular volume; however, ultrasound assessment of the inferior vena cava (IVC) is an effective tool for volume management. This study sought to determine the feasibility of using operators with limited ultrasound experience to assess IVC dimensions using hand-carried ultrasounds (HCU) in the outpatient clinical setting. The IVC was assessed in 89 consecutive patients at two outpatient clinics before and after HD. Intradialytic IVC was recorded during episodes of hypotension, chest pain, or cramping. High-quality IVC images were obtained in 79 of 89 patients. Despite that 89% of patients presented at or above dry weight, 39% of these patients were hypovolemic by HCU. Of the 75% of patients who left HD at or below goal weight, 10% were still hypervolemic by HCU standards. Hypovolemic patients had more episodes of chest pain and cramping (33 versus 14%, P = 0.06) and more episodes of hypotension (22 versus 3%, P = 0.02). The clinic with a higher prevalence of predialysis hypovolemia had significantly more intradialytic adverse events (58 versus 27%; P = 0.01). HCU measurement of the IVC is a feasible option for rapid assessment of intravascular volume status in an outpatient dialysis setting by operators with limited formal training in echocardiography. There is a poor relationship between dry weight goals and IVC collapsibility. Practice variation in the maintenance of volume status is correlated with significant differences in intradialysis adverse events.

Comparison of hand-carried ultrasound assessment of the inferior vena cava and N-terminal pro-brain natriuretic peptide for predicting readmission after hospitalization for acute decompensated heart failure.

OBJECTIVES We sought to compare the value of serial assessment with hand-carried ultrasound (HCU) of the inferior vena cava (IVC) with brain natriuretic peptide (BNP) to identify patients with acute decompensated heart failure (ADHF) who will be readmitted or seek emergency department treatment after hospital discharge. BACKGROUND Congestive heart failure (CHF) is a leading cause for hospitalization and, once hospitalized, patients with CHF frequently are readmitted. To date, no reliable index exists that can be used to predict whether patients with ADHF can be discharged with low readmission likelihood. METHODS A total of 75 patients who were admitted with a primary diagnosis of ADHF were followed. All patients were assessed at admission and discharge with the use of routine clinical evaluation, BNP measurement, and HCU evaluation of the IVC by physicians with limited training in ultrasound. RESULTS During the 30-day follow-up, 31 patients were rehospitalized or presented to the emergency department. Patients who were subsequently readmitted could not be differentiated from those who were not readmitted by their demographics, comorbidities, vital signs, presence of symptoms/signs suggestive of persistent congestion, hospital length of stay, or net volume removal. Routine laboratory tests, including assessment of renal function, also failed to predict readmission with the exception of serum sodium. Although admission BNP was similar in patients readmitted and not readmitted, pre-discharge log-transformed BNP was greater in patients who subsequently were readmitted. Patients who required repeat hospitalization had a larger IVC size on admission as well as at discharge. In addition, patients who were readmitted had persistently plethoric IVCs with lower IVC collapsibility indexes. At discharge, only serum sodium, log-transformed BNP, IVC size, and collapsibility were statistically significant predictors of readmission. CONCLUSIONS This study confirms that, once hospitalized, patients with CHF frequently are readmitted. Bedside evaluation of the IVC with a HCU device at the time of admission and discharge, as well as pre-discharge BNP, identified patients admitted with ADHF who were more likely to be readmitted to the hospital.

Usefulness of hand-carried ultrasound to predict elevated left ventricular filling pressure.

Detection of increased left ventricular filling pressure (LVFP) is paramount in the evaluation and treatment of patients with left heart failure, yet difficult to assess directly at the bedside. Although inferior vena cava (IVC) examination can detect increased right atrial pressure, a used surrogate for high LVFP, this assumption has not been directly tested. We evaluated whether assessment of IVC size and respirophasic variation could be used to predict increased LVFP. Seventy-two patients with chronic heart failure underwent right heart catheterization and limited echocardiographic examination focused on the IVC. IVC size and collapsibility were evaluated for their ability to predict a wedge pressure>or=15 mm Hg. In conclusion, an IVC maximum dimension of 2.0 cm and IVC collapsibility of 45% were the optimal cutoffs to predict an increased pulmonary capillary wedge pressure, with sensitivities of 75% and 83% and specificities of 83% and 71%, respectively.

Radiation Safety Among Cardiology Fellows

Cardiology fellows can be exposed to high radiation levels during procedures. Proper radiation training and implementation of safety procedures is of critical importance in lowering physician health risks associated with radiation exposure. Participants were cardiology fellows in the United States (n = 2,545) who were contacted by e-mail to complete an anonymous survey regarding the knowledge and practice of radiation protection during catheterization laboratory procedures. An on-line survey engine, SurveyMonkey, was used to distribute and collect the results of the 10-question survey. The response rate was 10.5%. Of the 267 respondents, 82% had undergone formal radiation safety training. Only 58% of the fellows were aware of their hospitals pregnancy radiation policy and 60% knew how to contact the hospitals radiation safety officer. Although 52% of the fellows always wore a dosimeter, 81% did not know their level of radiation exposure in the previous year and only 74% of fellows knew the safe levels of radiation exposure. The fellows who had received formal training were more likely to be aware of their pregnancy policy, to know the contact information of their radiation safety officer, to be aware of the safe levels of radiation exposure, to use dosimeters and RadPad consistently, and to know their own level of radiation exposure in the previous year. In conclusion, cardiology fellows have not been adequately educated about radiation safety. A concerted effort directed at physician safety in the workplace from the regulatory committees overseeing cardiology fellowships should be encouraged.

Quality of Care and Outcomes Among Patients With Acute Myocardial Infarction by Level of Kidney Function at Admission: Report From the Get With The Guidelines Coronary Artery Disease Program

Many patients admitted for acute myocardial infarction (AMI) have chronic renal insufficiency. We studied the impact of chronic renal insufficiency on mortality and quality of inpatient care for AMI from the American Heart Associations Get With The Guidelines–Coronary Artery Disease Program.

Instrumental Variable Analysis to Compare Effectiveness of Stents in the Extremely Elderly

Background—Evaluating novel therapies is challenging in the extremely elderly. Instrumental variable methods identify variables associated with treatment allocation to perform adjusted comparisons that may overcome limitations of more traditional approaches. Methods and Results—Among all patients aged ≥85 years undergoing percutaneous coronary intervention in nonfederal hospitals in Massachusetts between 2003 and 2009 (n=2690), we identified quarterly drug-eluting stent (DES) use rates as an instrumental variable. We estimated risk-adjusted differences in outcomes for DES versus bare metal stents using a 2-stage least squares instrumental variable analysis method. Quarterly DES use ranged from 15% to 88%. Unadjusted 1-year mortality rates were 14.5% for DES versus 23.0% for bare metal stents (risk difference, −8.5%; P<0.001), an implausible finding compared with randomized trial results. Using instrumental variable analysis, DES were associated with no difference in 1-year mortality (risk difference, −0.8%; P=0.76) or bleeding (risk difference, 2.3%; P=0.33) and with significant reduction in target vessel revascularization (risk difference, −8.3%; P<0.0001). Conclusions—Using an instrumental variable analysis, DES were associated with similar mortality and bleeding and a significant reduction in target vessel revascularization compared with bare metal stents in the extremely elderly. Variation in use rates may be useful as an instrumental variable to facilitate comparative effectiveness in groups underrepresented in randomized trials.

Is Optimal Medical Therapy “Optimal Therapy” for Multivessel Coronary Artery Disease? Optimal Management of Multivessel Coronary Artery Disease

When treating patients with coronary artery disease (CAD), clinicians consider whether management should be medical therapy (MT) alone or in addition to coronary revascularization. When revascularization is recommended, both coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) are potential options. Typically, the treatment recommendation is based on clinical presentation, severity and magnitude of ischemia, extent and distribution of coronary anatomic disease, presence of other noncardiac medical conditions, and evidence of the effectiveness of each strategy. Article see p 949 Recognizing the substantial differences and implications between an invasive and noninvasive approach, clinical investigators have conducted large-scale clinical trials to assess and compare MT to revascularization and CABG to PCI. The clinical applicability of such studies, however, may be limited by several factors. Firstly, enrollment in “strategy trials” is typically difficult and prolonged, and initially declared sample target endpoints are rarely achieved. Secondly, given the slowly progressive course of stable CAD, outcomes need to be assessed over a long period, thus delaying the answers to the proposed research questions. In addition, as both revascularization approaches and medical therapies evolve and become more refined over time, it may often be difficult to interpret study findings in the context of these “moving therapeutic targets.” A third concern relates to the types of patients enrolled in these studies and whether participating patients are truly reflective of those theoretically eligible. For example, some believe that once coronary anatomy has been defined in a patient with CAD and a judgment is rendered as to the suitability and appropriateness of revascularization, a treatment bias may significantly affect the decision as to whether or not a patient will be enrolled in a trial where treatment will be determined by random assignment. Despite these limitations and concerns, clinicians greatly value evidence derived from clinical trials comparing …

Comparison of Bare-Metal Stents and Drug-Eluting Stents in Coronary Ostial Lesions (from the National Heart, Lung, and Blood Institute Dynamic Registry)

We compared the effectiveness of drug-eluting stents (DESs) to bare-metal stents (BMSs) in ostial lesions from an unrestricted patient cohort with 3-year follow-up. DESs have proved more effective at decreasing repeat revascularization rates compared to BMSs in patients with uncomplicated coronary artery disease. Whether DESs provide similar benefits in ostial lesions is not clearly defined. We analyzed data from 775 patients in the National, Heart, Lung, and Blood Institute Dynamic Registry undergoing stenting of ostial lesions with DESs or BMSs. Patients were followed for 3 years for the occurrence of myocardial infarction (MI), repeat revascularization (coronary bypass surgery/repeat percutaneous coronary intervention), and death. In total 439 patients had 464 ostial lesions treated with BMSs and 336 patients had 351 ostial lesions treated with DESs. Adjusted DES versus BMS 3-year hazard ratios were 1.03 (95% confidence interval 0.60 to 1.78, p = 0.90) for death, 1.40 (0.83 to 2.37, p = 0.21) for MI, and 0.81 (0.59 to 1.11, p = 0.19) for repeat revascularization. In patients undergoing percutaneous coronary intervention for aorto-ostial disease (n = 200), death and repeat revascularization did not differ between stent types, but DES-treated patients had more MI during follow-up. For coronary ostial disease (n = 574), 3-year observed rates of death or MI did not differ; however, repeat revascularization was more common in the BMS group. In conclusion, use of DESs for ostial lesions was associated with no difference in the hazard of death, MI, or overall rates of repeat revascularization compared to BMS use.

Derivation and Validation of the CREST Model for Very Early Prediction of Circulatory Etiology Death in Patients Without ST-Segment–Elevation Myocardial Infarction After Cardiac Arrest

Background: No practical tool quantitates the risk of circulatory-etiology death (CED) immediately after successful cardiopulmonary resuscitation in patients without ST-segment–elevation myocardial infarction. We developed and validated a prediction model to rapidly determine that risk and facilitate triage to individualized treatment pathways. Methods: With the use of INTCAR (International Cardiac Arrest Registry), an 87-question data set representing 44 centers in the United States and Europe, patients were classified as having had CED or a combined end point of neurological-etiology death or survival. Demographics and clinical factors were modeled in a derivation cohort, and backward stepwise logistic regression was used to identify factors independently associated with CED. We demonstrated model performance using area under the curve and the Hosmer-Lemeshow test in the derivation and validation cohorts, and assigned a simplified point-scoring system. Results: Among 638 patients in the derivation cohort, 121 (18.9%) had CED. The final model included preexisting coronary artery disease (odds ratio [OR], 2.86; confidence interval [CI], 1.83–4.49; P⩽0.001), nonshockable rhythm (OR, 1.75; CI, 1.10–2.77; P=0.017), initial ejection fraction<30% (OR, 2.11; CI, 1.32–3.37; P=0.002), shock at presentation (OR, 2.27; CI, 1.42–3.62; P<0.001), and ischemic time >25 minutes (OR, 1.42; CI, 0.90–2.23; P=0.13). The derivation model area under the curve was 0.73, and Hosmer-Lemeshow test P=0.47. Outcomes were similar in the 318-patient validation cohort (area under the curve 0.68, Hosmer-Lemeshow test P=0.41). When assigned a point for each associated factor in the derivation model, the average predicted versus observed probability of CED with a CREST score (coronary artery disease, initial heart rhythm, low ejection fraction, shock at the time of admission, and ischemic time >25 minutes) of 0 to 5 was: 7.1% versus 10.2%, 9.5% versus 11%, 22.5% versus 19.6%, 32.4% versus 29.6%, 38.5% versus 30%, and 55.7% versus 50%. Conclusions: The CREST model stratified patients immediately after resuscitation according to risk of a circulatory-etiology death. The tool may allow for estimation of circulatory risk and improve the triage of survivors of cardiac arrest without ST-segment–elevation myocardial infarction at the point of care.